PNS Device for Chronic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of the Freedom PNS System, a peripheral nerve stimulation device, for individuals with persistent pain unresponsive to standard treatments. Researchers will review records from 40 individuals who already have this device implanted to assess changes in their pain over at least a year. The trial targets those with chronic nerve-related pain who have not found relief with other treatments. Participants must have the device implanted and be willing to attend follow-up visits. As an unphased trial, this study provides an opportunity to contribute to understanding the long-term benefits of an innovative pain management device.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are enrolled in another drug or device study.
What prior data suggests that the Freedom PNS System is safe for chronic pain patients?
Research has shown that the Freedom PNS System is safe and generally easy to use. Several studies have found it effective for chronic pain that does not improve with other treatments. One study focused on nerve pain in the legs reported no complications. Another study confirmed its safety and effectiveness in managing long-term pain. As a result, users of the Freedom PNS System typically do not experience serious side effects.12345
Why are researchers excited about this trial?
The Freedom PNS System is unique because it targets chronic pain through Peripheral Nerve Stimulation (PNS), offering a non-drug alternative that directly modulates nerve activity. Unlike standard treatments like opioids or NSAIDs, which can have significant side effects and dependencies, the Freedom PNS System provides pain relief by sending mild electrical pulses to nerves. Researchers are excited because this method could reduce reliance on medications, offering a safer and more sustainable pain management option.
What evidence suggests that the Freedom PNS System is effective for chronic pain?
Studies have shown that the Freedom PNS System effectively treats long-lasting pain. It significantly reduces pain levels and decreases the need for pain medications. Patients have experienced lasting pain relief for up to 24 months after using it. Research also indicates that people using this device enjoy a better quality of life. The Freedom PNS System is recognized for helping with pain that hasn't improved with other treatments.678910
Are You a Good Fit for This Trial?
This trial is for individuals with chronic, intractable pain from peripheral nerve issues that haven't improved with standard treatments. Participants must have had the Freedom PNS System implanted for at least a year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Retrospective Chart Review
A retrospective chart review will be conducted to assess baseline parameters in patients who have received a permanent implant with the Freedom PNS system.
Prospective Follow-up
Participants are monitored for safety and effectiveness after receiving the implant, with data collected on pain scores, opioid use, work status, sleep, and quality of life.
What Are the Treatments Tested in This Trial?
Interventions
- Freedom PNS System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Curonix LLC
Lead Sponsor
MetroHealth System, Ohio
Collaborator